The following data is part of a premarket notification filed by Medical Innovations Corp. with the FDA for Mic Anal Incontinence Tube.
| Device ID | K902684 |
| 510k Number | K902684 |
| Device Name: | MIC ANAL INCONTINENCE TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MEDICAL INNOVATIONS CORP. 1595 MC-CANDLESS DR. Milpitas, CA 95035 |
| Contact | Andersen |
| Correspondent | Andersen MEDICAL INNOVATIONS CORP. 1595 MC-CANDLESS DR. Milpitas, CA 95035 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-19 |
| Decision Date | 1990-09-12 |